Implantable and removable customizable body conduit

Abstract

An apparatus and method are provided to treat a stenosis. A delivery device is provided that has an elongate tubular member coupled therewith. The elongate tubular member has an outside surface that is configured to prevent adherence of in vivo matter. The tubular member has a proximal end and a distal end and is reinforced along its length to maintain open lumen under a transverse load. The tubular member is placed in the vasculature such that the distal end of the elongate tubular member is disposed distal of a stenosis. The proximal end of the elongate tubular member is disposed inside the vessel, preferably at a location proximal of the stenosis. Thereafter, after a therapeutic period, the elongate tubular member is removed intact.

1 . A method of treating a stenosis, comprising:
 providing a delivery device having an elongate tubular member coupled therewith, the elongate tubular member having an outside surface that is configured to prevent adherence of in vivo matter, the tubular member comprising a proximal end and a distal end and being reinforced to maintain an open lumen under a transverse load;   advancing the delivery device and the tubular member into the venous vasculature such that the distal end of the elongate tubular member is disposed distal of a stenosis and the proximal end of the elongate tubular member is disposed proximal of the stenosis in the venous vasculature;   separating the elongate tubular member from the delivery device to deploy the elongate tubular member, the deployed elongate tubular member displacing the stenosis radially outward to expand the vessel lumen; and   removing the elongate tubular member intact after a therapeutic period during which remodeling of the vessel occurs.   
     
     
         2 . The method of  claim 1 , wherein the delivery device is coupled with the elongate tubular member and applies an axial force to actuate the elongate tubular member from an expanded configuration capable of providing the open lumen to a low crossing profile configuration; the method further comprising:
 advancing tubular member on the delivery device in the low crossing profile configuration;   releasing the axial force on the elongate tubular member to cause the tubular member to move from the low crossing profile configuration to the expanded configuration.   
     
     
         3 . The method of  claim 2 , wherein releasing comprises applying a tension force to a tension member that extends through a lumen of the delivery device. 
     
     
         4 . The method of  claim 1 , wherein the tubular member includes a braided structure embedded therein. 
     
     
         5 . The method of  claim 4 , wherein the braided structure comprises a cylinder that has a first diameter under a tensile axial load and a second diameter larger than the first when not subject to the tensile axial load, the cylinder having a third diameter when under a compressive axial load, the third diameter being larger than the second diameter. 
     
     
         6 . The method of  claim 1 , wherein an outer surface of the tubular structure comprises a silicone material. 
     
     
         7 . The method of  claim 1 , wherein the tubular member has an expanded size that is greater than the size of the vessel without stenosis. 
     
     
         8 . The method of  claim 7 , wherein the tubular member has an expanded size that is about 20% greater than the size of the vessel without stenosis. 
     
     
         9 . The method of  claim 1 , wherein the therapeutic period is less than about 60 days. 
     
     
         10 . The method of  claim 1 , wherein removing the tubular member comprises:
 advancing a low profile elongate body through the vasculature;   engaging the elongate body with the tubular member; and   applying an axial load to actuate the tubular member from an expanded configuration to a low crossing-profile configuration.   
     
     
         11 . The method of  claim 1 , further comprising anchoring the tubular member by positioning tissue anchors proximally or distally of the stenosis. 
     
     
         12 . The method of  claim 1 , wherein the anchors comprise one or more of a suture, a cuff configured to promote adherence of in vivo matter, and a surface treatment to enhance frictional engagement. 
     
     
         13 . The method of  claim 1 , further comprising observing on at least two occasions the degree of enlargement of at least one of: (a) the size of tubular member, (b) the size of vessel segment being treated, (c) the flow through the tubular member, or (d) the flow through the vessel segment being treated to determine the therapeutic period. 
     
     
         14 . The method of  claim 1 , wherein the elongate body is configured to expand continuously during a majority of the therapeutic period. 
     
     
         15 . A method of bypassing a stenosis in the vasculature, comprising:
 coupling a first graft member with a first vessel segment upstream of the stenosis and a second graft member with a second vessel segment downstream of the stenosis;   coupling a first end of a blood flow conduit with the first graft member and a second end of the blood flow conduit with the second graft member by applying a connection force; and   disposing the first and second graft members and the blood flow conduit beneath the skin of the patient, such that both the first and second ends of the blood flow conduit are outside the vasculature;   wherein a force required to disconnect the blood flow conduit from the first or second graft is significantly higher than the connection force.   
     
     
         16 . The method of  claim 15 , wherein the blood flow conduit comprises a braided reinforcement embedded within a wall thereof along proximal and distal lengths of the conduit. 
     
     
         17 . The method of  claim 16 , further comprising:
 providing a connector to be disposed between at least one of (1) the first graft and the blood flow conduit and (2) the second graft and the blood flow conduit, the connector having at least one radial projection having an outer perimeter greater than the inner diameter of the blood flow conduit;   wherein coupling at least one of (1) the first graft with the blood flow conduit and (2) the second graft with the blood flow conduit comprising inserting at least a portion of the proximal and/or distal lengths of the blood flow conduit over the radial projection(s).   
     
     
         18 . A method of bypassing a stenosis and providing vascular access, comprising:
 providing a distal blood conduit and a proximal blood conduit comprising a graft and a connector having a retention feature located thereon, the distal blood conduit including a catheter comprising a braided structure embedded therein;   inserting a distal zone of the distal blood conduit into the vasculature and through a stenosis in the vasculature; and   advancing the catheter over a distal segment of the connector until at least a portion of the braided structure is positioned proximal of the retention feature.   
     
     
         19 . The method of  claim 18 , further comprising cutting the catheter through the braided structure to size the catheter in-situ prior to advancing the catheter over the distal segment of the connector. 
     
     
         20 . A system for bypassing a stenosis, comprising:
 a catheter having a proximal portion, a distal portion, and an elongate body extending between the proximal and distal portions, the elongate body defining an inner wall having an inner perimeter defining a blood flow lumen, the catheter having a braided structure embedded in the elongate body and disposed about the lumen; and   a first connector for fluidly coupling a first vascular graft with the proximal portion of the catheter, the connector comprising:
 a connector body having an outer surface defining a first outer perimeter and an inner surface defining a lumen; and 
 an engagement feature disposed on the outer surface of the connector body adjacent a distal end thereof, the engagement feature defining a second outer perimeter greater than the first outer perimeter; and 
   a second connector configured to securely engage a second vascular graft with the distal portion of the catheter;   wherein the proximal portion of the catheter has a first configuration in the free state wherein the inner perimeter is less than the first outer perimeter and a second configuration when in axial compression wherein the braided structure expands to permit the inner perimeter of the catheter body to expand such that the proximal end portion of the catheter can be advanced over the engagement feature of the connector body.   
     
     
         21 . The system of  claim 19 , further comprising a first vascular graft pre-connected to the first connector and a second vascular graft pre-connected to the second connector. 
     
     
         22 . The system of  claim 19 , wherein the second connector comprises:
 a connector body having an outer surface defining a first outer perimeter and an inner surface defining a lumen; and   an engagement feature disposed on an outer surface of the connector body adjacent a distal end thereof, the engagement feature defining a second outer perimeter greater than the first outer perimeter.